CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Provenge (sipuleucel‑T) coverage criteria

Defines coverage, inclusion and exclusion criteria, and authorization requirements for sipuleucel-T (Provenge) requests processed by the Utilization Management (UM) department for plan members. Applies to UM reviewers, ordering providers, and reimbursement decisions for Neighborhood Health Plan of Rhode Island membership managed by Evolent.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyProvenge (sipuleucel‑T) coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateDec 27, 2024

Next Review DateN/A

Key ActionObtain prior authorization and document supporting evidence (FDA labeling, CMS compendia, NCCN/ASCO guidelines, or peer‑reviewed literature) when requesting sipuleucel‑T.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3maximum doses allowed

Q2043HCPCS code

12/27/24policy effective

UM Deptapproval authority

Coverage, Inclusion, and Exclusion Criteria

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Coverage criteria and exclusions

Coverage is governed by inclusion/continuation rules and exclusion criteria. Continuation exemptions and exclusions apply as below.

Continuation exemption: Continuation requests exempt if ALL: (1) the requested medication was used within the last year, AND (2) the member has not experienced disease progression and/or intolerance to the requested medication, AND (3) additional medication(s) are not being added to the continuation request.

Exclusion criteria (deny if any met): (A) Disease progression while taking Provenge (sipuleucel-T); (B) Concurrent use with other anticancer therapies; (C) Dosing exceeds 3 doses given at approximately 2-week intervals; (D) Investigational or off‑label use lacking sufficient supporting evidence per policy evidentiary standards (see exclusions for detailed criteria).3 doses

Prostate cancer stance: Provenge (sipuleucel-T) is not supported by Evolent for metastatic castrate‑resistant prostate cancer due to lack of Level 1 evidence demonstrating superiority in progression‑free or overall survival compared to Evolent‑recommended alternative agents/regimens.

Exclusion criteria that will result in denial include: (A) disease progression while taking Provenge (sipuleucel‑T); (B) concurrent use with other anticancer therapies; (C) dosing that exceeds 3 doses given at approximately 2‑week intervals; and (D) investigational or off‑label use lacking sufficient supporting evidence per the policy’s evidentiary standards (e.g., absence of CMS‑recognized compendia support or acceptable peer‑reviewed literature meeting the outlined criteria).

Provenge (sipuleucel‑T) is not supported by Evolent for the treatment of metastatic castrate‑resistant prostate cancer. This position is based on the lack of Level 1 evidence (randomized trials and/or meta‑analyses) demonstrating superiority for progression‑free or overall survival compared with Evolent‑recommended alternative agents/regimens.

Requests for Provenge for indications that are investigational or off‑label without adequate supporting evidence are considered not approvable. The policy defines acceptable evidence as CMS‑recognized compendia or peer‑reviewed literature that address whether the patient population and regimen are represented, whether outcomes are clinically meaningful (for example, ASCO‑recommended benchmarks such as a hazard ratio < 0.80 or ≥3 months survival benefit where applicable), and whether study design and size provide reliable support; case reports and abstracts without full peer‑reviewed articles are generally insufficient.

Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization required. Evolent (on behalf of Neighborhood Health Plan of Rhode Island) must authorize Provenge (sipuleucel‑T) requests. Continuation requests are exempt from prior authorization when all the following are met: the medication was used within the last year; there is no documented disease progression and no intolerance to the medication; and no additional medications are being added to the continuation request.

Continuation exemption conditions: medication used within last year; no disease progression or intolerance; no additional medications added to continuation request.

Documentation Required

Support for use must be documented with one or more of the following: FDA-approved product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature that meets CMS standards (see Medicare Benefit Policy Manual Chapter 15).

Acceptable evidence sources: FDA labeling; CMS-approved compendia; NCCN or ASCO guidelines; acceptable peer‑reviewed literature meeting CMS criteria.

Denial Risk

Preferred Alternatives and Denial Trigger

Preferred alternatives referenced. Provenge (sipuleucel‑T) is not supported for metastatic castrate‑resistant prostate cancer due to lack of Level 1 evidence demonstrating superiority in progression‑free or overall survival versus Evolent‑recommended alternative agents/regimens (for example, regimens listed at http://pathways.newcenturyhealth.com). Requests for Provenge in this indication may be denied.

Evolent recommended alternatives (e.g., pathway regimens) are preferred where Level 1 evidence is lacking.
Example pathway resource: http://pathways.newcenturyhealth.com.

Denial Risk

Denial Triggers and Exclusion Criteria

Denial triggers include use with documented disease progression while on Provenge, concurrent use with other anticancer therapies, dosing that exceeds 3 doses given ~2‑week intervals, investigational or off‑label indications lacking sufficient evidence (per criteria below), or requests for metastatic castrate‑resistant prostate cancer where Level 1 evidence is absent. Sufficient evidence must address representativeness of patient/ cancer characteristics, regimen studied, clinically meaningful outcomes (ASCO‑recommended thresholds, e.g., HR <0.80 or ≥3‑month OS/PFS benefit), appropriate study design, and reliance on more than anecdotal case reports or abstracts without full peer‑reviewed publication.

Exclusion criteria: disease progression on Provenge; concurrent anticancer therapy; >3 doses (~2‑week intervals); investigational/off‑label use without sufficient evidence.
Evidence sufficiency considerations: representativeness, regimen relevance, clinically meaningful outcomes (ASCO guidance), appropriate study design, weight given to non‑randomized trials vs. case reports/abstracts.

Step	Preferred alternative(s) / pathway reference	Notes
1	Evolent-recommended alternative agents/regimens (see New Century Health pathways)	Provenge (sipuleucel‑T) is not supported by Evolent for metastatic castrate‑resistant prostate cancer due to lack of Level 1 evidence showing superiority in PFS or OS compared to recommended alternatives.

Quantity and Dose Limits

sipuleucel‑T — quantity/limits and exclusions

Maximum doses allowed3 doses per course, administered at approximately 2-week intervals

Continuation exemption conditionContinuation requests may be exempt from reauthorization if medication was used within the last year, member has not experienced disease progression or intolerance, and no additional medications are being added

Exclusion — disease progressionRequests should be denied if the member experienced disease progression while receiving sipuleucel‑T

Exclusion — concurrent therapyConcurrent use with other anticancer therapies is an exclusion

Exclusion — investigational/off‑label useInvestigational or off‑label indications lacking sufficient supporting evidence per CMS‑recognized compendia or acceptable peer‑reviewed literature are excluded

Background and Indication Context

Provenge (sipuleucel‑T) is an autologous cellular immunotherapy supplied and billed under HCPCS code Q2043 (sipuleucel‑t, minimum of 50 million autologous CD54+ cells activated with PAP‑GMCSF, including leukapheresis and preparatory procedures, per infusion). Evolent’s policy requires prior authorization for sipuleucel‑T and includes a mixed coverage stance: continuation requests may be exempt from reauthorization when criteria are met, but Provenge is not supported for metastatic castrate‑resistant prostate cancer due to insufficient Level‑1 evidence. Exclusion rules (disease progression on therapy, concurrent anticancer therapy, dosing beyond 3 infusions, or investigational/off‑label use without adequate evidence) inform denial decisions and guide UM reviewers and ordering providers when evaluating requests.